[Federal Register Volume 63, Number 28 (Wednesday, February 11, 1998)]
[Notices]
[Pages 7054-7056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Recombinant DNA Research: Proposed Actions Under the Guidelines

AGENCY: National Institutes of Health (NIH), PHS, DHHS.

ACTION: Notice of Proposed Actions Under the NIH Guidelines for 
Research Involving Recombinant DNA Molecules (NIH Guidelines).

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SUMMARY: This notice sets forth proposed actions that NIH plans to 
consider under the NIH Guidelines for Research Involving Recombinant 
DNA Molecules (59 FR 34496, amended 59 FR 40170, 60 FR 20726, 61 FR 
1482, 61 FR 10004, 62 FR 4782, 62 FR 53335, 62 FR 56196, 62 FR 59032). 
NIH invites all interested parties to submit comments concerning these 
proposals. The Recombinant DNA Advisory Committee (RAC) will consider 
these proposals at its meeting on March 10, 1998. After consideration 
of these proposals and comments by the RAC, the NIH Director will issue 
decisions according to the NIH Guidelines.

DATES: Comments received by March 2, 1998 will be reproduced and 
distributed to the RAC for consideration at its March 10, 1998, 
meeting.

ADDRESSES: Interested parties should submit written comments and 
recommendations to Debra Knorr, Office of Recombinant DNA Activities, 
National Institutes of Health, MSC 7010, 6000 Executive Boulevard, 
Suite 302, Bethesda, Maryland 20892-7010, Phone 301-496-9838, FAX 301-
496-9839.
    All comments received in response to this notice will be considered 
and will be available for public inspection in the ORDA offices on 
weekdays between the hours of 8:30 a.m. and 5:00 p.m.

FOR FURTHER INFORMATION CONTACT: Interested parties can obtain 
background documentation and additional information from the Office of 
Recombinant DNA Activities, National Institutes of Health, MSC 7010, 
6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, 
Phone 301-496-9838, FAX 301-496-9839. The Office of Recombinant DNA 
Activities web site is located at http://www.nih.gov/od/orda for 
further information about the office.

I. Proposed Actions Regarding Amendments to the NIH Guidelines

    The NIH will consider the following actions under the NIH 
Guidelines for Research Involving Recombinant DNA Molecules (NIH 
Guidelines):

I-A. Amendment to Appendix M-I, Submission Requirements--Human Gene 
Transfer Experiments, Under the NIH Guidelines Regarding Electronic 
Submission of Protocols

    In January 1998, Dr. C. Estuardo Aguilar-Cordova, a member of the 
RAC, participated in a pilot test with ORDA staff regarding electronic 
submission to ORDA. In this test, the documents submitted 
electronically included a human gene transfer protocol; responses to 
Appendices M-II through M-V, Points to Consider in the Design and 
Submission of Protocols for the Transfer of Recombinant DNA Molecules 
into One or More Human Subjects (Points to Consider); and the ORDA 
registration document. The 82-page electronic submission, including 
tables, satisfactorily proved the efficiency and effectiveness of using 
this method for submission of protocols.
    ORDA recognizes that electronic submission of documents is an 
accepted standard of practice within the scientific community; 
therefore, this practice is not novel. The practice of using this 
medium to submit formal protocols to ORDA, however, is novel and 
therefore requires amendments to the NIH Guidelines. As a result, ORDA 
proposes to amend Appendix M-I of the NIH Guidelines to provide 
guidance to investigators regarding optional electronic submission 
procedures.
    Electronic submission of human gene transfer protocols to ORDA 
offers several distinct advantages over the current practice of 
submitting protocols by printed matter, including: (1) ORDA can review 
protocols more expeditiously because they are received immediately; (2) 
electronic submission allows ORDA to search protocols electronically 
for keywords or phrases; (3) registration tasks performed at ORDA will 
be reduced substantially because the investigator has already completed 
most of the registration document as part of the electronic submission; 
and (4) ORDA can facilitate RAC review of the protocol by forwarding 
the complete protocol to RAC members electronically.
    Appendix M-I is proposed to read:

``Appendix M-I. Submission Requirements--Human Gene Transfer 
Experiments

    ``Investigators must submit the following material (see exemption 
in Appendix M-VIII-A, Footnotes of Appendix M) to the Office of 
Recombinant DNA Activities, National Institutes of Health/MSC 7010, 
6000 Executive Boulevard, Suite 302, Bethesda, Maryland 20892-7010, 
Phone 301-496-9838, FAX 301-496-9839. Investigators may submit this 
material electronically and can obtain specific instructions from the 
ORDA home page (http://www.nih.gov/od/orda) regarding electronic 
submission requirements. For all submissions, whether printed or 
electronic, ORDA will confirm receipt within three working days after 
receiving the submission. Investigators should contact ORDA if they do 
not receive this confirmation.
    ``Proposals in printed form and/or in an electronic version shall 
be submitted to NIH/ORDA in the following order: (1) scientific 
abstract; (2) non-technical abstract; (3) Responses to Appendix M-II 
through M-V, Description of the Proposal, Informed Consent, Privacy and 
Confidentiality, and Special Issues (the pertinent responses can be 
provided in the protocol or as an appendix to the protocol); (4) 
clinical protocol as approved by the local Institutional Biosafety 
Committee and Institutional Review Board; (5) Informed Consent document 
as approved by the Institutional Review Board (see Appendix M-III, 
Informed Consent); (6) appendices (including tables, figures, and 
manuscripts); and (7) curricula vitae-- no more than 2 pages for each 
key professional person in biographical sketch format.
    ``All submissions must include Institutional Biosafety Committee 
(IBC) and Institutional Review Board (IRB) approvals and their 
deliberations pertaining to your protocol. IBC approval must be 
obtained from each institution at which recombinant DNA material will 
be administered to human subjects (as opposed to each institution 
involved in the production of vectors for human application and each 
institution at which there is ex vivo transduction of recombinant DNA 
material into target cells for human application). Because these 
written IBC and IRB approvals require appropriate signatures, 
investigators cannot submit them electronically. Investigators should 
submit these signed approvals either by mail or by facsimile 
transmission.
    ``Investigational New Drug (IND) applications shall be submitted to 
the FDA in the format described in 21 CFR, Chapter I, Subchapter D, 
Part 312, Subpart B, Section 23, IND Content and Format. Submissions to 
the FDA should be sent to the Division of Congressional and Public 
Affairs, Document Control Center, HFM-99, Center for Biologics 
Evaluation and Research, 1401 Rockville Pike, Rockville, Maryland 
20852-1448.

    Note: NIH/ORDA will accept submission material at any time. 
However, if a protocol is submitted less than eight weeks before a 
scheduled RAC meeting and subsequently is recommended for public 
discussion by the full RAC, the public discussion of that protocol 
will be deferred until the next scheduled RAC meeting. This eight-
week period is needed to ensure adequate time for review by the 
committee members.

    OMB's ``Mandatory Information Requirements for Federal Assistance 
Program Announcements'' (45 FR 39592) requires a statement concerning 
the official government programs contained in the Catalog of Federal 
Domestic Assistance. Normally NIH lists in its announcements the number 
and

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title of affected individual programs for the guidance of the public. 
Because the guidance in this notice covers virtually every NIH and 
Federal research program in which DNA recombinant molecule techniques 
could be used, it has been determined not to be cost effective or in 
the public interest to attempt to list these programs. Such a list 
would likely require several additional pages. In addition, NIH could 
not be certain that every Federal program would be included as many 
Federal agencies, as well as private organizations, both national and 
international, have elected to follow the NIH Guidelines. In lieu of 
the individual program listing, NIH invites readers to direct questions 
to the information address above about whether individual programs 
listed in the Catalog of Federal Domestic Assistance are affected.

    Date: January 28, 1998.
Lana R. Skirboll,
Associate Director for Science Policy, National Institutes of Health.
[FR Doc. 98-3492 Filed 2-10-98; 8:45 am]
BILLING CODE 4140-01-P